OUR PEOPLE

MedHimalayas has integrated expertise with the latest technologies to meet the client needs. Our professionals have the competence and regulatory knowledge to meet the needs of our customers keeping up with the compliance standards in the areas of Pharmacovigilance, Data Management and Medical writing. 

We have a pool of talented professionals to facilitate with uninterrupted and smooth running of ongoing projects. 

The pharmacovigilance unit consists of experienced Medical writers, Data Associates, Pharmacovigilance officers, Drug safety physicians, Pharmacovigilance project leads and Pharmacovigilance manager. 

The team is supported and monitored by the best international industry Pharmacovigilance and regulatory consultants all of whom have many years experience of European and FDA operational structure. 

OUR WORKING

Our pharmacovigilance and drug safety unit work closely with our clinical research, data management, regulatory and medical writing team. Pharmacovigilance forms the core of our working processes.

MedHimalayas use a fully validated, industry-standard 21 CFR Part 11 compliant database for SAE management, reporting and regulatory reporting (including E2B). The system is web-based and allows us for maximum flexibility and scalability according to the operational scale of our clients.